Manufacturer
Lumenis Be, Ltd.Stellar M22
Country / Region:Israel (IL)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250809
- Device name
- Stellar M22
- Company
- Lumenis Be, Ltd.
- Country / Region
- Israel(IL)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-03-17
- Decision date
- 2025-04-16
- Submission type
- Special
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Hair removalPigment treatmentVascular treatmentSkin resurfacing
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The Lumenis Stellar M22 system has connection capability with the following available treatment modules, for multi-application treatment options. All modules are designed for aesthetic and dermatological skin procedure application, as follows: ● IPL with a spectrum of 400-1200nm (with different filters) is indicated for: o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). o Cutaneous lesions, including warts, scars and striae. o Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. o Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. o Mild to moderate inflammatory Acne (Acne Vulgaris). ● Multi-Spot Nd:YAG Laser, with a wavelength of 1064 nm is indicated for: o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg. o The non-ablative treatment of facial wrinkles. o The removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. ● The 1565nm ResurFX module, with a wavelength of 1565 nm, is indicated for: o Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue. ● Q-Switched Nd:YAG Laser, with a wavelength of 1064 nm, is indicated for: o Treatment of pigmented lesions. o Removal of dark tattoos. (*) Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen.
Intended Use
The Lumenis Stellar M22 system has connection capability with the following available treatment modules, for multi-application treatment options. All modules are designed for aesthetic and dermatological skin procedure application, as follows: ● IPL with a spectrum of 400-1200nm (with different filters) is indicated for: o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). o Cutaneous lesions, including warts, scars and striae. o Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. o Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. o Mild to moderate inflammatory Acne (Acne Vulgaris). ● Multi-Spot Nd:YAG Laser, with a wavelength of 1064 nm is indicated for: o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg. o The non-ablative treatment of facial wrinkles. o The removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. ● The 1565nm ResurFX module, with a wavelength of 1565 nm, is indicated for: o Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue. ● Q-Switched Nd:YAG Laser, with a wavelength of 1064 nm, is indicated for: o Treatment of pigmented lesions. o Removal of dark tattoos.
Device Description
The Lumenis Stellar M22 System is multi-application, multi-technology system intended for use in aesthetic dermatologic procedures. The Stellar M22 System operates with four (4) treatment handpieces options (for connection capability), within serial operational mode: • Intense Pulsed Light (IPL) handpiece; • Multi-Spot Nd:YAG Laser handpiece; • ResurFX Laser module and handpiece; • Q-Switched Nd:YAG laser handpiece. The following accessories are provided with and/or may be purchased independently for each of the four (4) available treatment handpieces of the Stellar M22 for Intense Pulsed Light (IPL) and Laser Systems: • The Stellar IPL handpiece has nine (9) different filters available: Cut-off filters of 515, 560, 590,615, 640, 695 and 755 nm, Notch Filters of 400-600 & 800-1200 nm and 530650&900-1200 nm. Further, the IPL handpiece has three (3) Sapphire Cool LightGuides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6 mm diameter. • The Multi-Spot Nd:YAG handpiece has three (3) different LightGuides available in sizes of: 2mm x 4mm, 6 mm, and 9 mm. • The ResurFX handpiece has two (2) different treatment tips available: SapphireCool and Precision tips • The Q-Switched Nd:YAG handpiece has both disposable and gold-plated metal treatment tips available. The disposable treatment tips are available in four (4) different sizes of: 2, 2.5, 3.5, and 5 mm, while the metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.
Summary parsed at:2026-06-01 05:22:39 UTC
Predicate devices
1Stellar M22 for Intense Pulsed Light (IPL) and Laser System
K250809 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K250809 as a predicate
